与反应性监测相比，积极监测英夫利昔单抗血清浓度可改善炎症性肠病患者的长期预后。
Improved Long-term Outcomes of Patients With Inflammatory Bowel Disease Receiving Proactive Compared With Reactive Monitoring of Serum Concentrations of Infliximab.
机构信息
Center for Inflammatory Bowel Diseases, Division of Gastroenterology, Beth-Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Department of Medicine, Division of Gastroenterology, Duke University School of Medicine, Durham, North Carolina.
出版信息
Clin Gastroenterol Hepatol. 2017 Oct;15(10):1580-1588.e3. doi: 10.1016/j.cgh.2017.03.031. Epub 2017 Mar 30.
BACKGROUND & AIMS: Monitoring serum concentrations of tumor necrosis factor antagonists in patients receiving these drugs as treatment for inflammatory bowel disease (IBD), also called therapeutic drug monitoring, is performed either after patient loss of response (reactive drug monitoring) or in patients in clinical remission in which the drug is titrated to a target concentration (proactive drug monitoring). We compared long-term outcomes of patients with IBD undergoing proactive vs reactive monitoring of serum concentrations of infliximab.
METHODS
We performed a multicenter, retrospective study of 264 consecutive patients with IBD (167 with Crohn's disease) receiving infliximab maintenance therapy. The subjects received proactive (n = 130) or reactive (n = 134) drug monitoring, based on measurements of first infliximab concentration and antibodies to infliximab, from September 2006 to January 2015; they were followed through December 2015 (median time of 2.4 years). We analyzed time to treatment failure, first IBD-related surgery or hospitalization, serious infusion reaction, and detection of antibodies to infliximab. Treatment failure was defined as drug discontinuation for loss of response or serious adverse event, or need for surgery.
RESULTS
Multiple Cox regression analysis independently associated proactive drug monitoring, compared with reactive monitoring, with reduced risk for treatment failure (hazard ratio [HR], 0.16; 95% confidence interval [CI], 0.09-0.27; P < .001), IBD-related surgery (HR, 0.30; 95% CI, 0.11-0.80; P = .017), IBD-related hospitalization (HR, 0.16; 95% CI, 0.07-0.33; P < .001), antibodies to infliximab (HR, 0.25; 95% CI, 0.07-0.84; P = .025), and serious infusion reaction (HR, 0.17; 95% CI, 0.04-0.78; P = .023).
CONCLUSIONS
In a retrospective analysis of patients with IBD receiving proactive vs reactive monitoring of serum concentration of infliximab, proactive monitoring was associated with better clinical outcomes, including greater drug durability, less need for IBD-related surgery or hospitalization, and lower risk of antibodies to infliximab or serious infusion reactions.
背景与目的
监测接受肿瘤坏死因子拮抗剂治疗炎症性肠病（IBD）患者的血清浓度（也称为治疗药物监测），可以在患者失去反应（反应性药物监测）时进行，也可以在药物滴定至目标浓度时在临床缓解的患者中进行（主动药物监测）。我们比较了接受英夫利昔单抗主动监测与被动监测的 IBD 患者的长期结局。
方法
我们对 264 例连续接受英夫利昔单抗维持治疗的 IBD 患者（167 例克罗恩病）进行了一项多中心、回顾性研究。根据英夫利昔单抗首次浓度和英夫利昔单抗抗体的测定，患者接受主动（n=130）或被动（n=134）药物监测，研究时间为 2006 年 9 月至 2015 年 1 月；通过 2015 年 12 月（中位时间 2.4 年）随访。我们分析了治疗失败、首次 IBD 相关手术或住院、严重输液反应和英夫利昔单抗抗体的检出时间。治疗失败定义为因失去反应或严重不良事件而停药、需要手术。
结果
多因素 Cox 回归分析独立显示，与被动监测相比，主动药物监测与治疗失败风险降低相关（风险比[HR]，0.16；95%置信区间[CI]，0.09-0.27；P<0.001）、IBD 相关手术（HR，0.30；95%CI，0.11-0.80；P=0.017）、IBD 相关住院（HR，0.16；95%CI，0.07-0.33；P<0.001）、英夫利昔单抗抗体（HR，0.25；95%CI，0.07-0.84；P=0.025）和严重输液反应（HR，0.17；95%CI，0.04-0.78；P=0.023）。
结论
在对接受英夫利昔单抗主动与被动监测血清浓度的 IBD 患者的回顾性分析中，主动监测与更好的临床结局相关，包括更高的药物持久性、更少的 IBD 相关手术或住院需求，以及更低的英夫利昔单抗抗体或严重输液反应风险。
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